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VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)

NCT ID: NCT05715125

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-01-02

Brief Summary

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The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.

Detailed Description

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This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of VTX958 tablets, Dose A and Dose B, in adults with active Psoriatic Arthritis. Approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, VTX958 Dose A, VTX958 Dose B, or placebo, for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of LTE, and a 30 day follow-up period.

Conditions

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Psoriatic Arthritis

Keywords

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TYK2 inhibitor Psoriatic arthritis Ventyx VTX958 Tranquility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned at the beginning of the study to either Dose A, Dose B, or placebo group, where they stay for the remainder of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The study has a double-blind design, meaning that the participant, care provider, and investigator will not know what treatment group each participant has been assigned to. This blinding will last from randomization until the end of the study.

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

VTX958 Dose A

Group Type EXPERIMENTAL

Dose A VTX958

Intervention Type DRUG

Dose A VTX958

VTX958 Dose B

Group Type EXPERIMENTAL

Dose B VTX958

Intervention Type DRUG

Dose B VTX958

Interventions

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Dose A VTX958

Dose A VTX958

Intervention Type DRUG

Dose B VTX958

Dose B VTX958

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening
* Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis
* Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1
* Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product
* Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product

Exclusion Criteria

* Has non-plaque psoriasis at Screening or Day 1
* Has inflammatory bowel disease or active uveitis
* Has a history of chronic or recurrent infectious disease
* Has a known immune deficiency or is immunocompromised
* Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ventyx Biosciences, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matt Cascino, MD

Role: STUDY_DIRECTOR

Ventyx Biosciences, Inc

Locations

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Site # 840001

Phoenix, Arizona, United States

Site Status

Site # 840016

Newport Beach, California, United States

Site Status

Site # 840004

Clearwater, Florida, United States

Site Status

Site # 840014

Miami Lakes, Florida, United States

Site Status

Site # 840017

Lexington, Kentucky, United States

Site Status

Site # 840018

Okemos, Michigan, United States

Site Status

Site #840012

Saint Clair Shores, Michigan, United States

Site Status

Site # 840019

Eagan, Minnesota, United States

Site Status

Site # 840003

Middleburg Heights, Ohio, United States

Site Status

Site # 840007

Duncansville, Pennsylvania, United States

Site Status

Site # 840010

Baytown, Texas, United States

Site Status

Site # 840006

Lubbock, Texas, United States

Site Status

Site # 840015

Mesquite, Texas, United States

Site Status

Site # 840011

Beckley, West Virginia, United States

Site Status

Site # 840008

South Charleston, West Virginia, United States

Site Status

Site # 100004

Haskovo, , Bulgaria

Site Status

Site # 100001

Plovdiv, , Bulgaria

Site Status

Site # 100002

Plovdiv, , Bulgaria

Site Status

Site # 203004

Hlučín, , Czechia

Site Status

Site # 203001

Ostrava, , Czechia

Site Status

Site # 203003

Pardubice, , Czechia

Site Status

Site # 203005

Prague, , Czechia

Site Status

Site # 203002

Zlín, , Czechia

Site Status

Site # 276002

Berlin, , Germany

Site Status

Site # 276001

Hamburg, , Germany

Site Status

Site # 348003

Budapest, , Hungary

Site Status

Site # 348001

Hódmezővásárhely, , Hungary

Site Status

Site # 348004

Kistarcsa, , Hungary

Site Status

Site # 616015

Gdynia, , Poland

Site Status

Site # 616007

Katowice, , Poland

Site Status

Site # 616010

Krakow, , Poland

Site Status

Site # 616009

Lodz, , Poland

Site Status

Site # 616012

Lodz, , Poland

Site Status

Site # 616014

Lodz, , Poland

Site Status

Site # 616013

Lublin, , Poland

Site Status

Site # 616002

Nadarzyn, , Poland

Site Status

Site # 616011

Olsztyn, , Poland

Site Status

Site # 616004

Poznan, , Poland

Site Status

Site # 616008

Torun, , Poland

Site Status

Site # 616006

Warsaw, , Poland

Site Status

Site #616001

Warsaw, , Poland

Site Status

Site # 616003

Wroclaw, , Poland

Site Status

Site # 616016

Wroclaw, , Poland

Site Status

Site # 724002

A Coruña, , Spain

Site Status

Site # 724005

Lleida, , Spain

Site Status

Site # 724001

Seville, , Spain

Site Status

Countries

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United States Bulgaria Czechia Germany Hungary Poland Spain

Other Identifiers

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VTX958-203

Identifier Type: -

Identifier Source: org_study_id